HB-adMSCs for the Treatment of Crohn's Disease

Primary Objective:

• To investigate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in Crohn's Disease Activity Index (CDAI) scores. (Time Frame: Week 0 to Week 52). Minimal clinically important difference (MCID) for CDAI is defined as a decrease of ≥100 points.

Secondary Objectives:

• To assess the safety of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by the incidence of adverse events or serious adverse events. (Time Frame: Week 0 to Week 52).
• To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in fecal calprotectin (FC) values. (Time Frame: Week 0 to Week 52). Clinically significant changes in fecal calprotectin (FC) values are defined as a ≥50% reduction in fecal calprotectin concentration from baseline, or a decrease to <250 µg/g, whichever is achieved first.

Exploratory Objectives:

• To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in CRP values. (Time Frame: Week 0 to Week 52).
• To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in ESR values. (Time Frame: Week 0 to Week 52).

Inclusion criteria

• Male and female subjects who are ≥ 18 years old and ≤ 65 years old.
• Must be diagnosed with Crohn's Disease at least 6 months prior to the screening visit, as verified by one or more of the following diagnostic criteria present in the participant's medical records:

• Clinical presentation of symptoms such as diarrhea, abdominal pain, weight loss, fever, and fatigue
• Radiologic Findings within 3 years of screening date: Imaging studies like CT scans or MRI scans of the abdomen and pelvis that indicate bowel wall thickening, strictures, fistulas, and abscesses characteristic of Crohn's disease
• Histologic Findings within 3 years of screening date: Microscopic examination of tissue biopsies that indicate transmural inflammation with lymphoid infiltrates
• Exclusion of other conditions: Differential diagnoses, such as ulcerative colitis, infectious enterocolitis, and drug-induced colitis, must be excluded through appropriate evaluation
• Must have CDAI scores at the screening visit of ≥ 150 to ≤ 450, indicating Mild or Moderate Crohn's Disease.
• Subjects without a current established treatment for Crohn's Disease, or if being treated, subjects who are on a stable dose of Crohn's Disease therapy regimen for ≥3 months prior to screening.
• Subjects must be willing to maintain their established treatment for Crohn's Disease (or lack thereof) for the duration of the study. Subjects must acknowledge that they may be removed from participation in the study for failure to maintain their established treatment for Crohn's Disease (or lack thereof).
• Subjects must have an elevated CRP value at the screening visit of ≥1 mg/L and/or an abnormal ESR value at the screening visit of &gt; 15 mm/hr. for male subjects or &gt; 20 mm/hr. for female subjects.
• Subjects must be able to provide the latest (specifically, within 3 years of screening date) diagnostic imaging records for their Crohn's Disease (including but not limited to endoscopy, colonoscopy, MRI scans, ultrasounds, etc.)
• Female study subjects of childbearing potential should not be pregnant or plan to become pregnant during study participation and for 6 months after the last investigational product administration. Female study subjects of childbearing potential must confirm usage of one of the following contraceptive measures:

• Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
• Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
• Barrier contraceptive methods (condoms, diaphragm, etc.). OR Male subjects if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during study participation and for 6 months after the last administration of the investigated product:.

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• Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
• Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
• Barrier contraceptive methods (condoms, diaphragm, etc.).
• Study subjects are able and willing to comply with the requirements of this clinical trial.
• Voluntarily signed informed consent from study subject or legally authorized representative obtained before any clinical-trial related procedures are performed.

Exclusion criteria

• Study subject has any of the following laboratory results at the screening visit:

• WBC: &lt;3000 cells/μL OR &gt;15000 cells/μL (&lt;3 K cells/μL or &gt;15 K cells/μL)
• Absolute Neutrophil Count: &lt;1500 cells/μL
• Sodium: &lt;120 mEq/L OR &gt;150 mEq/L
• Glucose: &gt;150 mg/dL (for fasting subjects)
• Potassium: &lt;3.5 mEq/L OR &gt;6 mEq/L
• BUN: &gt;25 mg/dL
• Creatinine: &gt;2 mg/dL
• BUN/Creatinine ratio: &gt;50
• Study subject has CDAI scores of &lt; 150 or &gt; 450 at the screening visit.
• Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.
• Study subject has any of the following cardiovascular issues:

• Severe heart failure (e.g., NYHA Class III/IV)
• Uncontrolled arrhythmias
• Recent myocardial infarction (&lt;6 months from screening visit)
• Uncontrolled hypertension
• Study Subject has any of the following pulmonary diseases:

• Severe COPD
• Pulmonary fibrosis
• History of recent (&lt;6 months from screening visit) pulmonary embolism or DVT
• Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:

• Diabetes Mellitus
• Rheumatoid Arthritis
• Lupus
• Multiple Sclerosis
• Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
• Study subject has a history of cancer within 5 years of screening visit (unless curatively treated and without recurrence)
• Study subject has known alcoholic addiction or dependency or has current substance use or abuse.
• Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines.
• Study subject has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study.
• Study subject unable to understand and provide signed informed consent.
• Study subject unlikely to complete the study or adhere to the study procedures.
• Study subject with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.
• Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.
• Female subjects who plan to donate eggs or undergo in vitro fertilization treatment during the study within 6 months after the last infusion. OR Male subjects who plan to donate sperm during the study within 6 months after the last infusion.